None listed
Conditions
Brief summary
A pressure injury, or pressure ulcer, is localised damage to the skin and/or underlying tissue caused by unrelieved pressure, shear or friction. Some hospital patients develop pressure injuries- with those in intensive care units at increased risk because they are critically ill and immobile. Several strategies are recommended in the international clinical practice guidelines for the prevention of pressure injuries. One strategy is the use of prophylactic foam dressings to prevent sacral pressure injuries, yet it remains unclear if these dressings prevent pressure injuries. More recently, sub-epidermal moisture scanners, which detect the early tissue damage associated with pressure injuries, are used by some clinicians during their daily patient skin assessment. A benefit for clinicians is they can use the scanner measurements to implement early and targeted pressure injury prevention strategies before skin redness is visible to the naked eye. The aim of this pilot study is to determine the feasibility of conducting a larger three-arm randomised controlled trial that will test the effectiveness of two different prophylactic foam dressings, sub-epidermal moisture scanners versus usual care to prevent sacral pressure injuries in adult intensive care patients.
Interventions
*Arm 1: Mepilex® Border Sacrum (Molnlycke®) (dressing 1), sacral Sub-epidermal moisture
(SEM) scanner and usual pressure injury prevention (PIP) care (Intervention 1);
Dressing 1: involves the Research Nurse applying the Mepilex® Border dressing to the patient's sacrum on study recruitment and changed as per the manufacturer's recommendations. The Research Nurse will check the dressing each day. The manufacturer recommends the dressing is changed when the edge begins to roll and lose adhesion or
*Arm 1: Mepilex® Border Sacrum (Molnlycke®) (dressing 1), sacral Sub-epidermal moisture (SEM) scanner and usual pressure injury prevention (PIP) care (Intervention 1); Dressing 1: involves the Research Nurse applying the Mepilex® Border dressing to the patient's sacrum on study recruitment and changed as per the manufacturer's recommendations. The Research Nurse will check the dressing each day. The manufacturer recommends the dressing is changed when the edge begins to roll and lose adhesion or it becomes soiled. Dressings will also be changed if saturation of the dressing occurs, staff accidentally remove the dressing or if the dressing becomes dislodged. The dressing will be removed when the patient reaches any of the trial end points. *Arm 2: Allevyn Life Sacrum (Smith+Nephew) (dressing 2), sacral SEM scanner and usual PIP care (Intervention 2); Dressing 2: involves the Research Nurse applying the Allevyn Life Sacrum (Smith + Nephew) dressing to the patient's sacrum on study recruitment and changed as per the manufacturer's recommendations. The Research Nurse will check the dressing each day. An inbuilt ‘dressing change indicator’ signals when the dressing should be replaced. Dressings will also be changed saturation and soiling of the dressing occurs, if the adhesive edges ‘roll’, staff accidentally remove the dressing or if the dressing becomes dislodged. The dressing will be removed when the patient reaches any of the trial end points. Trial end points and study exit: • Develop sacral Hospital-acquired pressure injury (HAPI) (any stage); • Commence prone positioning; • Require droplet precautions; • Discharged from ICU; • Die; • Develop faecal/urinary incontinence, – whichever occurs first. SEM Scanner: on recruitment and each data collection day, the Research Nurse will 'peel back' the dressing, take a digital photograph of the sacrum and undertake a non-invasive scan of the sacral skin using a SEM scanner. Usual PIP care includes regular skin inspection and assessment, second hourly repositioning, elevating heels off the bed, pressure relieving heel boots, and use of pressure redistributing mattresses.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*Aged 18 years and older; *Assessed by Intensive Care Unit staff as being at high-risk for Pressure Injury (Research Nurse to confirm eligibility using Waterlow score equal to or greater than 15 AND Braden scale score equal to or less than 13); *Anticipated Intensive Care Unit length of stay of 48 hours and longer; *Study recruitment occurs within the first 24-hours of the patient’s Intensive Care Unit admission *Patient, or their nominated proxy, can provide informed consent.
Exclusion criteria
*Patient requiring prolonged prone positioning as part of their ongoing care; *Patients receiving end-of-life or terminal care; *Patients requiring droplet infection control precautions such as patients with COVID-19 infections; *Any clinical condition that prevents the patient from being turned as determined by the Intensive Care Unit team; *Pre-existing sacral Pressure Injury or other injury/skin condition/allergy; *Urinary or faecal incontinence at the time of recruitment; *Prescribed sacral topical cream that reduces dressing adherence; *Unable to speak or understand English without a hospital interpreter present.
Outcome results
None listed